Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Pilot Study of Eovist (Gadoxetate) Enhanced MRI for the Detection of Prostate Cancer

Status Completed

Clinical Trial Summary

Background:

• Prostate cancer is the most common cancer type among men. Some prostate cancers respond to hormonal therapy. However, some cell characteristics of other prostate cancers cause it not to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast agent used to help identify damaged liver tissue, can help tell these types of prostate cancer apart. It may be able to identify if a man has a type of prostate cancer for which hormone therapy may not work as well.

Objectives:

• To see if gadoxetate can help identify different types of prostate cancers during imaging studies.

Eligibility:

• Men at least 18 years of age who have prostate cancer. Participants will be having surgery to either remove the prostate or take tumor tissue samples.

Design:

• Participants will be screened with a physical exam and medical history. Blood samples will be collected.

• Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They will receive gadoxetate during the MRI scan.

• Participants who have surgery will have a sample of their tumor cells collected. Those who have a biopsy will provide cells from this biopsy for study.

• Treatment will not be provided as part of this study.

Clinical Trial Description

BACKGROUND:

• Prostate cancer is the most common non-cutaneous malignancy among men in the western world. Prognostic biomarkers would be useful in stratifying patients to different treatments.

• The expression of a testosterone membrane transporter, organic anion-transporting polypeptide 1B3 (OATP1B3), is associated with shorter time to progression after hormonal ablation therapy and shorter overall survival in prostate cancer patients. 52% of localized prostate cancer lesions express OATP1B3, while 92% of prostate cancer metastases requiring hormonal ablation treatment, express OATP1B3 in soft tissue lesions. Expression of OATP1B3 also correlates with Gleason grade.

• Current imaging methods cannot predict treatment failure or resistance.

• Gadoxetate disodium (Gd-EOB-DTPA) (Eovist , Bayer HealthCare Pharmaceuticals Inc. Pittsburgh, PA) is an MR imaging agent which is FDA-approved gadolinium chelate for detecting hepatocellular carcinoma (HCC), as normal hepatocytes express OATP1B3 while most hepatocellular carcinomas (HCC) do not. However, those HCCs that do take up Eovist have been shown to express OATP1B3.

• Eovist may be useful to evaluate OATP1B3 status in patients with prostate cancer and may therefore serve as a prognostic and treatment biomarker.

PRIMARY OBJECTIVE:

-Evaluate the uptake and retention of Eovist in prostate cancers.

ELIGIBILTY:

• Male subjects greater than or equal to 18 years old

• Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2

• Subjects with clinically localized prostate cancer must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 immunohistochemistry (IHC).

• Subjects with advanced disease who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring greater than or equal to1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for OATP1B3 IHC.

or

-Subjects, for whom tissue is not available, must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

DESIGN:

• This pilot study will accrue 25 subjects divided into two arms: 10 evaluable subjects with localized prostate cancer and 15 evaluable subjects with advanced disease

• Each subject will receive a single intravenous (IV) dose of Eovist by bolus injection

• All subjects will undergo magnetic resonance imaging (MRI) prior to and immediately after, 10, 20 and 60 minutes post-Eovist injection ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01867424
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 2
• Start date: May 14, 2013
• Completion date: December 8, 2016